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Chemical Sterilization - Patent 4923677

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United States Patent: 4923677


































 
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	United States Patent 
	4,923,677



 Simon
,   et al.

 
May 8, 1990




 Chemical sterilization



Abstract

Dental and medical instruments and appliances are chemically sterilized by
     immersion in or subjection to a formulation or composition comprising as
     active antimicrobial agents a combination or admixture of an iodophor such
     as the povidone-iodine complex or a quaternary ammonium compound such as
     cetyl pyridinium chloride and a peroxide such as H.sub.2 O.sub.2, the
     antimicrobial action of the iodine derived from the iodophor being
     enhanced or potentiated by oxygen released from the peroxide. The
     invention is applicable also to the chemical sterilization of surgical
     sites. Procedure for making and using the sterilizing formulation or
     composition is described.


 
Inventors: 
 Simon; Gilbert I. (Bronxville, NY), Witkin; Roy T. (Westport, CT) 
 Assignee:


Witkin; Roy T.
 (Westport, 
CT)


Simon; Gilbert I.
 (Bronxville, 
NY)





Appl. No.:
                    
 06/763,469
  
Filed:
                      
  August 7, 1985





  
Current U.S. Class:
  422/37  ; 422/28; 422/29; 424/613; 424/616; 424/672
  
Current International Class: 
  A01N 59/12&nbsp(20060101); A61L 2/18&nbsp(20060101); A61L 002/18&nbsp()
  
Field of Search: 
  
  





 422/37,28,12,29 424/130,150
  

References Cited  [Referenced By]
U.S. Patent Documents
 
 
 
4113857
September 1978
Shetty

4521403
June 1985
Simon et al.

4526751
July 1985
Gartner

4567036
January 1986
Simon et al.

4592487
June 1986
Simon et al.

4592488
June 1986
Simon et al.

4592489
June 1986
Simon et al.



 Foreign Patent Documents
 
 
 
2718385
Feb., 1976
DE

2438594
Nov., 1978
DE



   
 Other References 

Open for public inspection--AU 8423-635A published 7/26/84, Olin Corp.
.
Kirk-Othmer, Encyclopedia of Chemical Technology, vol. 7, pp. 802-803, vol. 13, pp. 649-655, 660-674.
.
U.S. E.P.A. Pesticide Guidelines, Subdivision G; Product Performance (Nov. 1928; PB83-153924) Section 91-30-5, "Disinfection Efficacy Against Viruses"..  
  Primary Examiner:  Richman; Barry S.


  Assistant Examiner:  Johnston; Jill


  Attorney, Agent or Firm: Jacobs & Jacobs



Claims  

What is claimed is:

1.  A method of chemically sterilizing dental and surgical instruments before, during and after use which comprises subjecting the dental and surgical instruments for a short
but sufficient period of time to effect sterilization thereof to the action of a freshly prepared antimicrobial solution comprising an admixture of a separate solution of an iodophor component which is a source of derived solubilized iodine and a
peroxide component in solution which is a source of active or nascent oxygen, the components when admixed being in aqueous solution in proportions to provide 1% to 2% by weight of derived iodine such that the oxygen released from the peroxide potentiates
the antimicrobial activity of the iodine derived from the iodine source, admixing the two components to form the solution and sterilizing the dental and surgical instruments therewith.


2.  A method according to claim 1 wherein the iodophor component is povidone iodine and the peroxide component is H.sub.2 O.sub.2.


3.  A method according to claim 1 wherein the sterilization is carried out by immersing or dipping the dental and surgical instruments in the antimicrobial solution.


4.  A method according to claim 1 wherein the sterilization is carried out by washing, spraying or rinsing the dental and surgical instruments with the anti-microbial enhanced solution.


5.  A method according to claim 1 wherein the sterilization is carried out in an container or compartment containing a supply of the sterilizing solution.


6.  A method of chemically sterilizing dental and surgical instruments and appliances according to claim 1 wherein the available iodine of the povidone iodine solution is approximately 2%.


7.  A method of chemically sterilizing dental and surgical instruments according to claim 1 wherein the instruments are cleansed of organic matter and debris prior to sterilization and rinsed with sterile water and dried subsequent to
sterilization.


8.  A method of chemically sterilizing dental and surgical instruments which comprises separately preparing an antimicrobial aqueous solution of an iodophor, separating preparing an aqueous solution of a peroxide, maintaining the solutions out of
contact with one another, introducing predetermined amounts of said solutions into a receptacle in which the sterilization is carried out and in which receptacle the separate solutions form an admixture, placing the dental and surgical instruments to be
sterilized in said admixture so that they are fully immersed in or covered by said admixed solutions, rendering them free of live microorganisms by such subjection to the admixed solutions and thereafter removing the instruments and appliances from said
admixed solutions which have interacted with each other so that the oxygen released from the peroxide potentiates the antimicrobial activity of the iodine derived from the iodophor.


9.  A method according to claim 8 wherein the iodophor is an aqueous solution of providone iodine and the peroxide is hydrogen peroxide.  Description  

The present invention relates to sterilization
and more particularly to chemical sterilization for rendering dental and medical instruments and appliances and actual and potential surgical sites sterile and free from live microbials.


Dental and medical instruments and appliances during use become unavoidably contaminated or soiled by microbials, both pathogens and non-pathogens such as bacteria, yeast, fungi and viral matter and before those dental and medical instruments and
appliances can be used or re-used they must be treated to make them free from microbial, viral and other forms of contamination such as blood, tissue and mucus.  Many of such dental and medical instruments and appliances are made of expensive steels and
alloys and it is thus desired to keep them ready for continued use since it would be uneconomical and wasteful to have to replace them with new sterile instruments and appliances after each use.


The usual practice in the sterilization of various metal and alloy instruments and appliances has been to subject them to autoclaving, at the temperature of a hot-air oven or boiling water to destroy or remove live micro-organisms and spores. 
Other procedures are carried out by sound, gases, e.g. ethylene oxide, light and .gamma.-ray irradiation or sometimes by disinfectant iodine solutions.  While such practices may be generally satisfactory, the usual thermal or conventional procedure
leaves open the possibility of incomplete or inconvenient time-consuming sterilization and the requirement for special equipment and experienced personnel. 

In accordance with the present invention, dental and medical instruments and appliances of
the usual nature employed in dental and medical practice are sterilized by means of simple, inexpensive commercially available chemicals having together exceptional antimicrobial and viricidal properties at ambient temperature and atmospheric conditions,
and sterilization need only be carried out for a short period of time, e.g. 5 minutes, thereby avoiding the disadvantages and expense of thermal autoclaving or other prior known sterilizing procedures.  More particularly, the chemical sterilization is
carried out by immersing in or otherwise physically subjecting the dental and medical instruments and appliances to an antimicrobial solution admixture which comprises as its major active components an iodophor such as the povidone-iodine complex (PVP-I)
and H.sub.2 O.sub.2, the iodine derived from the PVP-I being potentiated or enhanced in its anti-microbial activity by the active or nascent oxygen from the peroxide.  This combination of PVP-I and H.sub.2 O.sub.2 solutions maximizes the antimicrobial
activity and shortens the time required for sterilization.


We have found that when dental and medical instruments and appliances require sterilization, such can be quickly and inexpensively carried out by means of an anti-microbial solution containing PVP-I and H.sub.2 O.sub.2 or other peroxy compound
such as carbamide peroxide or benzoyl peroxide, wherein the PVP-I as a source of derived iodine and the peroxide as a source of oxygen are preferably but not necessarily present in predetermined relative proportions to provide enhanced or potentiated
antimicrobial and viricidal activity.  Such a solution, which is an admixture of the PVP-I and the peroxide, has been found to have surprising and unexpected enhanced antimicrobial activity against gram-positive and gram-negative bacteria and bacterial
viruses and other microbial contaminants so that the admixture has a wide effective spectrum of antimicrobial activity for sterilization purposes.


According to the invention and illustrative of sterilization against the bacterial virus T-7, viricidal activity of multiple combinations of PVP-I and H.sub.2 O.sub.2 were conducted to demonstrate maximized activity by the method described in
U.S.  EPA Pesticide Assessment Guidelines Subdivision G: Product Performance (November 1982; PB83-153924) Section91-30-5-"Disinfection Efficacy Against Viruses", which procedure determines the reduction in viral titre after a five minute exposure to the
agent.  Each such determination was carried out in quadruplicate.


Stock solutions of H.sub.2 O.sub.2 (35% H.sub.2 O.sub.2 DuPont Albone 35 CG) and PVP-I (20% PVP-I solution having 2.2% available iodine) were diluted in sterile distilled water to the desired concentrations just prior to experimentation.


To microtitre plate wells, 10 .mu.L of virus suspension (10.sup.6-7 VP/ml in 5% fetal calf serum) were added and allowed to air dry.  An aliquot (28 .mu.L) of H.sub.2 O.sub.2, PVP-I or combination was added to wells containing the dried virus and
contacted for 5 minutes, after which the aliquot was withdrawn and placed into another microtitre plate whose wells contained 250 .mu.L nutrient broth which was previously inoculated with the virus host, Escherichia coli bacteriophage (ATCC 5177). 
Serial dilutions (1:10) were carried out in this plate until the viral inoculum was diluted 10.sup.8 times.  Viral viability was determined by lysis of the viral host, i.e., the absence of bacterial growth as measured by absorbance at 450 .mu.m. 
Toxicity of the H.sub.2 O.sub.2, PVP-I and combinations thereof to the host organism was also determined.


 TABLE 1  ______________________________________ Relationship of T-7 Titre Reduction (in logs)  to Various Concentrations of PVP-I and H.sub.2 O.sub.2  Singly and in Combination  PVP-I (%) H.sub.2 O.sub.2 (%)  Log Reduction 
______________________________________ 0 .gtoreq.6 0  0.2 0 1  0.1 0 .gtoreq.1  0.1 3 3  0.15 3 4  0.15 1.5 3  ______________________________________


The above table shows the degree of viral kill as measured in log reduction of viral titre after exposure to various concentrations and combinations of H.sub.2 O.sub.2 and PVP-I, the concentrations of PVP-I in all instances being as percent of
available iodine.  Enhancement or potentiation of activity was determined to exist if the PVP-I/H.sub.2 O.sub.2 combinationsexhibited a greater than expected degree of viricidal activity than was observed by the use of the agents singly or additively and
as will be noted from Table 1, the degree of viricidal activity of the PVP-I/H.sub.2 O.sub.2 combinations is greater than their individual activities or their merely additive activities and hence the combinations showed enhanced or potentiated activity.


 TABLE 2  ______________________________________ Viricidal Concentrations of PVP-I and H.sub.2 O.sub.2  Singly and in Combination Against Bacteriophage  T-7 That Show a 4 Log Reduction in Virus Titre  PVP-I Conc.(%) H.sub.2 O.sub.2 Conc.(%) 
______________________________________ 0.3 0  0.15 3  0 12  ______________________________________


The concentrations of PVP-I and H.sub.2 O.sub.2 singly and in combination in Table 2 further demonstrate the attainment of enhanced or potentiated activity for the PVP-I/H.sub.2 O.sub.2 combination, as indicated by a 4 log reduction in viral
titre.


It is further to be understood that the present invention relates not only to the chemical sterilization of dental and medical instruments and appliances used by dentists, dental surgeons, physicians and surgeons, but that it also includes the
application of the sterilizing aqueous or aqueous alcoholic solutions or formulations to surgical sites by washing, spraying or swabbing whether the surgical sites result from use of the instruments and appliances or whether skin or body areas are to be
sterilized preparatory to surgery.  In the normal use of dental and surgical instruments and appliances there may well be resultant surgical sites as from incisions or operations which require treatment to prevent infection or the spread of infection.


For this purpose the same compositions or solutions are utilized as for the chemical sterilization of the instruments and appliances themselves, i.e. a composition of an iodophor such as PVP-I and a peroxy compound releasing oxygen for enhancing
or potentiating the antimicrobial activity of the iodine derived from the iodophor.  The active or nascent oxygen released from H.sub.2 O.sub.2 or other peroxide has been found to markedly increase the antimicrobial effectiveness of the iodine derived
from (PVP-I, and in the chemical sterilization of the instruments and appliances, the iodophor and the source of oxygen are preferably but not necessarily present in predetermined relative proportions, so long as the relationship gives a maximal peak of
activity for sterilization purposes.  The sterilizing composition or solution is initially in the form of separate components or solutions which are maintained out of physical contact with one another until it is desired to combine and use the same for
sterilization purposes, or the components may be premixed in a suitable dual comparmented or partitioned container or vessel and discharged together just shortly before use at ambient temperature and atmospheric conditions.  When freshly combined the
PVP-I and H.sub.2 O.sub.2 solutions have the maximal sterilizing activity in the shortest period of time.


The surgical sites are treated by applying the admixed components thereto and this may be carried out by means of a swab, spray or applicator and, if necessary, the site covered by a bandage to assist in healing while at the same time preventing
access of undesirable contaminants to such treated sites.  The particular manner and formulation of application of the antimicrobial components or solutions may be varied, depending upon the nature and extent of the surgical site and its location on or
in a human body.  For this purpose, the chemical sterilizing components or solutions may be formulated into a lotion, paste, gel, ointment, spray, cream or surgical scrub especially where the surgical site is in a location to which an aqueous solution
might not adhere for a sufficient length of time to ensure complete sterilization.  The sterilizing compositions may also be formulated as a vaginal or rectal douche or suppository when the surgical sites or infections are located in those areas.


It is further understood that the invention, whether used to sterilize dental and surgical instruments and appliances or to be applied to surgical sites, may further comprise an iodophor such as PVP-I or other nonoxynol surfactant carrier or
complexing agent for iodine, e.g. Biopal (GAF Corp.), and further may include alternative suitable sources of active or nascent oxygen other than H.sub.2 O.sub.2, such as carbamide peroxide and benzoyl peroxide.  Sodium chlorite, which is a source of
chlorine dioxide ClO.sub.2, may be included as an oxygen source.


The basic materials or non-active components in compositions for chemical sterilizaton according to the present invention, exclusive of the iodophor and peroxide, when not in aqueous or aqueous alcoholic solution form, are formulated with the
usual or conventional ingredients in known manner to form pastes, gels, lotions, ointments, creams, sprays, surgical scrubs and other semi-liquid or semi-solid formulations or to form rectal and vaginal douches, enemas or suppositories so long as the
active components are present in suitable proportions for effective antimicrobial activity.  The non-active components per se form no part of the present invention.  Typical formulations of the above types involving PVP-I are published in BASF
publication 30/06 Register 4 of 09/80.


The PVP-I is incorporated into one portion of each such formulation and the H.sub.2 O.sub.2 is incorporated into another like portion and the portions are admixed just prior to their use, or they may be formulated and pre-mixed in a suitable dual
compartmented or partitioned receptacle or container from which they are discharged together shortly before use.


In the preferred manner of practicing the invention, used or post-operative dental and surgical instruments and appliances are cleansed of all organic matter such as blood, tissue and mucus by detergent washing or ultrasonically to remove all
debris following which the instruments and appliances are rinsed sterilized as above described by immersion or subjection to the chemical sterilizing solutions or compositions.  Thereafter, the now sterilized instruments and appliances are removed from
the sterilizing solutions or compositions, rinsed with sterile water to ensure complete removal of any residual matter and placed under or between sterile towels and permitted to dry.


In utilizing the aqueous or aqueous alcoholic forms of sterilization, the available iodine need be only about 2% in the case of instruments and appliances, whereas solutions for the treatment of surgical sites need have only about 1% available
iodine for effective sterilization.  The concentration of an H.sub.2 O.sub.2 or other peroxide solution as a source of nascent or active oxygen is not critical relative to the available iodine so long as enough oxygen is released to interact with or upon
at least an appreciable part of the available iodine to enhance or potentiate the antimicrobial activity of the available iodine.  This iodine/oxygen relation can be 1:1 v/v but can also be less such as one-tenth to one-half oxygen ratio relative to the
iodine percentage.


Other and further variations and modifications of the invention may be made as will be appreciated by dental and surgical technicians without departing from the scope or concept of the invention as defined by the sub-joined claims.


* * * * *























				
DOCUMENT INFO
Description: The present invention relates to sterilizationand more particularly to chemical sterilization for rendering dental and medical instruments and appliances and actual and potential surgical sites sterile and free from live microbials.Dental and medical instruments and appliances during use become unavoidably contaminated or soiled by microbials, both pathogens and non-pathogens such as bacteria, yeast, fungi and viral matter and before those dental and medical instruments andappliances can be used or re-used they must be treated to make them free from microbial, viral and other forms of contamination such as blood, tissue and mucus. Many of such dental and medical instruments and appliances are made of expensive steels andalloys and it is thus desired to keep them ready for continued use since it would be uneconomical and wasteful to have to replace them with new sterile instruments and appliances after each use.The usual practice in the sterilization of various metal and alloy instruments and appliances has been to subject them to autoclaving, at the temperature of a hot-air oven or boiling water to destroy or remove live micro-organisms and spores. Other procedures are carried out by sound, gases, e.g. ethylene oxide, light and .gamma.-ray irradiation or sometimes by disinfectant iodine solutions. While such practices may be generally satisfactory, the usual thermal or conventional procedureleaves open the possibility of incomplete or inconvenient time-consuming sterilization and the requirement for special equipment and experienced personnel. In accordance with the present invention, dental and medical instruments and appliances ofthe usual nature employed in dental and medical practice are sterilized by means of simple, inexpensive commercially available chemicals having together exceptional antimicrobial and viricidal properties at ambient temperature and atmospheric conditions,and sterilization need only be carried out for a short period of time, e.g. 5 minute